Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer (NCT01943695) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
United States144 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.
The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
Who can participate
Age range
21 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 21-80 years
* Female
* MSK histologically confirmed early-stage operable breast cancer
* Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
* ECOG status of 0 or 1
* Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
* If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
a. Women \< 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
* Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
* Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
* A respiratory exchange ratio ≥ 1.10;
* Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
* Willingness to be randomized to one of the study arms
Exclusion Criteria:
* Presence of any other concurrent, actively treated malignancy
* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
* Presence of metastatic …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in VO2 peak (functional capacity)
Timeframe: during chemotherapy 3-6 months depending on treatment recommendations